Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

Taipei Medical University

Status and phase: Unknown; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Other: customized insoles; Other: ready made insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT01765101

SKH-8302-102-DR-32

Details and patient eligibility

About

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.

Full description

A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
• with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment

Exclusion criteria

• with a history of previous knee surgery with an implant
• reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
• pregnant or planning to become pregnant
• self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

customized insoles

Experimental group

Description:

customized full-length lateral wedged shoe insoles 1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Treatment:

Other: customized insoles

ready made insoles

Placebo Comparator group

Description:

ready-made full-length lateral wedged shoe insoles at 1 and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Treatment:

Other: ready made insoles